Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program

Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program

First participants dosed atNYU Grossman School of MedicineandUniversity of Maryland School of Medicine

Pfizer and BioNTechramping up manufacturing capabilitiesto further increaseproduction capacity in 2020/2021

NEW YORK, USA, and MAINZ, Germany, May5, 2020 – Pfizer Inc.(NYSE:PFE) and BioNTechSE (Nasdaq: BNTX) announced today that thefirst participants have been dosed in the U.S. in the Phase 1/2clinical trial for the BNT162 vaccine program to prevent COVID-19.The trial is part of a global development program, and the dosing ofthe first cohort in Germany was completed last week.

The Phase 1/2 study is designedto determine the safety,immunogenicity andoptimal dose level of four mRNA vaccinecandidates evaluated in a single, continuous study. The doselevelescalation portion(Stage 1) of the Phase 1/2 trial in the U.S. willenroll up to 360 healthy subjectsinto two age cohorts (18-55 and65-85 years of age). The first subjects immunized in Stage 1 of thestudy will be healthy adults 18-55 years of age. Older adultswillonly be immunized with a given dose level of a vaccine candidateonce testing of that candidate and dose levelin younger adults hasprovided initial evidence of safety and immunogenicity. Sitescurrently dosing participantsincludeNYU Grossman School of Medicine and the University of Maryland School of Medicine, withtheUniversity of RochesterMedical Center/Rochester Regional HealthandCincinnati Children’s HospitalMedical Center to begin enrollmentshortly.

“With our unique androbust clinical study programunderway,starting in Europe and now the U.S., we look forward to advancingquickly and collaboratively with our partners at BioNTech andregulatory authorities to bring a safe and efficacious vaccine tothe patients who need it most. The short,less than four-monthtimeframe in which we’ve been able to move from pre-clinical studiesto human testing isextraordinary and further demonstrates ourcommitment to dedicating our best-in-class resources, from the labto manufacturing and beyond, in the battle against COVID-19,” saidAlbert Bourla, Chairman and CEO, Pfizer.

Pfizer and BioNTech’s development program includes fourvaccinecandidates, each representing a different combination ofmRNA formatand target antigen.The novel design of the trial allows for theevaluation of the various mRNAcandidates simultaneously in order toidentify the safest andpotentially most efficacious candidatein a greater number of volunteers,in a manner that will facilitate thesharing of data with regulatory authorities in real time.

“It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine programin such a short period. We are optimistic that advancingmultiplevaccine candidates into human trials will allow us to identify thesafest, most effective vaccination options against COVID-19,” saidCEO and Co-founder of BioNTech, Ugur Sahin.

During the clinical development stage, BioNTech will provideclinical supply of the vaccine from its GMP-certified mRNAmanufacturing facilities in Europe.

In anticipation of a successful clinical development program, Pfizerand BioNTech are working to scale up production for global supply.

Pfizer plans to activate its extensive manufacturing networkandinvest at risk in an effort to produce an approved COVID-19 vaccineas quickly as possible for those most in need around the world. Thebreadth of this program should allow production of millions ofvaccine doses in 2020, increasing to hundreds of millions in 2021.Pfizer-owned sites in three U.S. states (Massachusetts, Michigan andMissouri) and Puurs, Belgiumhave been identified as manufacturingcenters for COVID-19 vaccine production, with more sites to beselected. Through its existing mRNA production sites in Mainz andIdar-Oberstein, Germany, BioNTech plans to ramp up its productioncapacity to provide further capacities for a global supply of thepotential vaccine.

BioNTech and Pfizer will work jointly to commercialize the vaccineworldwide upon regulatory approval (excluding China, whereBioNTechhas a collaborationwith Fosun Pharma for BNT162 for both clinicaldevelopment and commercialization).

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bringtherapies to people that extend and significantly improve theirlives. We strive to set the standard for quality, safety and valuein the discovery, development and manufacture of health careproducts, including innovative medicines and vaccines. Every day,Pfizer colleagues work across developed and emerging markets toadvance wellness, prevention, treatments and cures that challengethe most feared diseases of our time. Consistent with ourresponsibility as one of the world's premier innovativebiopharmaceutical companies, we collaborate with health careproviders, governments and local communities to support and expandaccess to reliable, affordable health care around the world. Formore than 170 years, we have worked to make a difference for all whorely on us. We routinely post informationthat may be important toinvestors on our website at www.Pfizer.com. In addition, to learnmore, please visit us on www.Pfizer.com and follow us on Twitter at

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Pfizer Disclosure Notice

The information contained in this release is as of May5,2020.Pfizer assumes no obligation to update forward-looking statementscontained in this release as the result of new information or futureevents or developments.

This release contains forward-looking information about Pfizer’sefforts to combat COVID-19, BioNTech’s mRNA vaccine program, BNT162, a collaboration between BioNTech and Pfizer to develop a potentialCOVID-19 vaccine and manufacturing capacity, including theirpotential benefits, and the expected timing of clinical trials andpotential supply, that involves substantial risks and uncertaintiesthat could cause actual results to differ materially from thoseexpressed or implied by such statements. Risks and uncertaintiesinclude, among other things, the uncertainties inherent in researchand development, including the ability to meet anticipated clinicalendpoints, commencement and/or completion dates for clinical trials,regulatory submission dates, regulatory approvaldates and/or launchdates, as well as the possibility of unfavorable new clinical dataand further analyses of existing clinical data; the risk thatclinical trial data are subject to differing interpretations andassessments by regulatory authorities; whether regulatoryauthorities will be satisfied with the design of and results fromthe clinical studies; whether and when any biologics licenseapplications may be filed in any jurisdictions for any potentialvaccine candidates under the collaboration; whether and when anysuch applications may be approved by regulatory authorities, whichwill depend on myriad factors, including making a determination asto whether the product’s benefits outweigh its known risks anddetermination of the product’s efficacy and, if approved, whetherany such vaccine candidates will be commercially successful;decisions by regulatory authorities impacting labeling,manufacturing processes, safety and/or other matters that couldaffect the availability or commercial potential ofany such vaccinecandidates, including development of products or therapies by othercompanies; manufacturing capabilities or capacity; uncertaintiesregarding the ability to obtain recommendations from vaccinetechnical committees and other public healthauthorities regardingany such vaccine candidates and uncertainties regarding thecommercial impact of any such recommendations; and competitivedevelopments.

A further description of risks and uncertainties can be found inPfizer’s Annual Report on Form10-K for the fiscal year endedDecember 31, 2019 and in its subsequent reports on Form 10-Q,including in the sections thereof captioned “Risk Factors” and“Forward-Looking Information and Factors That May Affect FutureResults”, as well as in its subsequent reports on Form 8-K, all ofwhich are filed with the U.S. Securities and Exchange Commission andavailable at www.sec.gov and www.pfizer.com.

About BioNTech

Biopharmaceutical New Technologies (BioNTech) is a next generationimmunotherapy company pioneering novel therapies for cancer andother serious diseases. The Company exploits a wide array ofcomputational discovery and therapeutic drug platforms for the rapiddevelopment of novel biopharmaceuticals. Its broad portfolio ofoncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancerantibodies and small molecules. Based on its deep expertise in mRNAvaccine development and in-house manufacturing capabilities,BioNTech and its collaborators are developing multiple mRNA vaccinecandidates for a range of infectious diseases alongside its diverseoncology pipeline. BioNTech has established a broad set ofrelationships with multiple global pharmaceutical collaborators,including Eli Lilly and Company, Genmab, Sanofi, Bayer AnimalHealth, Genentech, a member of the Roche Group, Genevant, FosunPharma, and Pfizer. For more information, please

visit www.BioNTech.de.

BioNTech Forward-looking statements

Thispressreleasecontains“forward-lookingstatements”ofBioNTechwithinthemeaningofthePrivateSecuritiesLitigationReformAct of 1995.Theseforward-lookingstatementsmayinclude,butmaynotbelimitedto,statementsconcerning:BioNTech’seffortstocombatCOVID-19;thetimingtoinitiateclinicaltrialsofBNT162;collaborationsbetweenBioNTechandPfizer,andBioNTechandFosunPharma,todevelop a potentialCOVID-19vaccine;and the abilityofBioNTechtosupplythequantitiesofBNT162tosupportclinicaldevelopmentand,ifapproved,marketdemand.Anyforward-lookingstatementsinthispressreleasearebasedonBioNTechcurrentexpectationsandbeliefsoffutureevents,andaresubjectto a numberofrisksanduncertaintiesthatcouldcauseactualresultstodiffermateriallyandadverselyfromthosesetforthinorimpliedbysuchforward-lookingstatements.Theserisksanduncertaintiesinclude,butarenotlimitedto:competitiontocreate a vaccineforCovid-19andpotentialdifficulties.For a discussion of theseandotherrisksanduncertainties,seeBioNTech’sAnnualReport on Form 20-F filedwiththeSEConMarch31,2020,whichhasbeenfiledwiththeSECandisavailableontheSEC’swebsiteatwww.sec.gov. Allinformationinthispressreleaseisasofthedateoftherelease,andBioNTechundertakesno duty to update this information unless required by law.